A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Overview[ - collapse ][ - ]

Purpose Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
ConditionEpilepsies, Partial
InterventionDrug: gabapentin
PhasePhase 3
SponsorPfizer
Responsible PartyPfizer
ClinicalTrials.gov IdentifierNCT00620555
First ReceivedFebruary 11, 2008
Last UpdatedJanuary 24, 2012
Last verifiedNovember 2011

Tracking Information[ + expand ][ + ]

First Received DateFebruary 11, 2008
Last Updated DateJanuary 24, 2012
Start DateMay 2008
Estimated Primary Completion DateDecember 2010
Current Primary Outcome MeasuresNumber of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [Time Frame: up to 53 weeks] [Designated as safety issue: Yes]Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Current Secondary Outcome Measures
  • Response Ratio [Time Frame: Up to 52 weeks] [Designated as safety issue: No]The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
  • Responder Rate [Time Frame: Up to 52 weeks] [Designated as safety issue: No]Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).
  • Percent Change in Seizure Frequency [Time Frame: Up to 52 weeks] [Designated as safety issue: No]Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Official TitleA 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473)
Brief Summary
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric
patients with partial seizures
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionEpilepsies, Partial
InterventionDrug: gabapentin
Orally administered gabapentin
Study Arm (s)Experimental: gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment65
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010
Eligibility Criteria
Inclusion Criteria:

- Completion of study A9451162 (NCT00603473)

Exclusion Criteria:

- Seizures related to drugs or acute medical illness

- History of any serious medical or psychiatric disorder
GenderBoth
Ages3 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesJapan

Administrative Information[ + expand ][ + ]

NCT Number NCT00620555
Other Study ID NumbersA9451165
Has Data Monitoring CommitteeNo
Information Provided ByPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators Study Director: Pfizer CT.gov Call Center Pfizer
Verification DateNovember 2011

Locations[ + expand ][ + ]

Pfizer Investigational Site
Obu-shi,Morioka-machi, Aichi, Japan
Pfizer Investigational Site
Jonan-ku, Fukuoka, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Suma-Ku,Kobe, Hyogo, Japan
Pfizer Investigational Site
Kanazawa, Ishikawa, Japan
Pfizer Investigational Site
Zentsuuji, Kagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa Pref., Japan
Pfizer Investigational Site
Sendai-shi, Miyagi-ken, Japan
Pfizer Investigational Site
Showa-Ku, Nagoya, Japan
Pfizer Investigational Site
Niigata-shi, Niigata, Japan
Pfizer Investigational Site
Kurashiki-City, Okayama Pref., Japan
Pfizer Investigational Site
Okayama-shi, Okayama, Japan
Pfizer Investigational Site
Izumi-shi, Osaka, Japan
Pfizer Investigational Site
Miyakojima-ku, Osaka, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Shizuoka-shi, Shizuoka, Japan
Pfizer Investigational Site
Kodaira, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Saitama, Japan
Pfizer Investigational Site
Yamagata, Japan